Glucosamine Periodontal Adjunctive Therapy

Ain Shams University

Status and phase: Terminated; Early Phase 1

Conditions: Chronic Periodontitis

Treatments: Drug: lactose capsules; Drug: glucosamine sulphate

Study type: Interventional

Funder types: Other

Identifiers

NCT02214095

randomized clinical trial

Details and patient eligibility

About

This study is the first evidence based work evaluated the systemic use of glucosamine as an adjunctive therapy to closed mechanical debridement in chronic periodontitis. The use of glucosamine sulphate was correlated with clinical outcomes and IL1-β level in the GCF of patients with moderate to advanced chronic periodontitis

Full description

Targeting the inflammatory response may be a rational approach to the medical treatment of chronic periodontitis. Glucosamine sulphate (GS) was proven to have anti-inflammatory actions with minimal side effect profile. Objectives; The main objectives of this study were to evaluate clinically the efficacy of GS; as a novel adjunctive host modulating agent in periodontal therapy and to investigate its effect on gingival crevicular fluid (GCF) level of IL-1β. Methods; Forty patients with moderate to severe chronic periodontitis (CP) were included in this study. They were randomly divided into two groups. Group I (G1) patients (n=20) received 500 mg GS capsules three times daily for 3 months following full mouth scaling and root planing (SRP), while group II (G2) patients (n=20) received a placebo for the same period following full mouth SRP. Clinical periodontal parameters and GCF IL-1β levels were analyzed at baseline and 3 months following therapy.

Enrollment: 40 patients

Sex: All

Ages: 35 to 48 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. good compliance with the plaque control instructions following initial therapy
2. each subject contributed a single premolar or molar tooth with interproximal probing depth ≥ 5 mm and clinical attachment loss ≥ 4 mm
3. teeth involved were all vital with score 0-1 mobility
4. availability for the follow-up and maintenance program;

Exclusion criteria

1. no systemic diseases which could influence the outcome of therapy as evidenced by Burket's Oral Medicine health history questionnaire
2. absence of periodontal treatment for the previous year
3. absence of systemic medication or antibiotic treatment for the previous six months
4. absence of a smoking habit.
5. post menopausal, pregnant or breast feeding women were excluded from participating in the study. Patients with contraindications to glucosamine sulphate therapy e.g., hypersensitivity to any of the product's components or with inadequate compliance with the oral hygiene maintenance schedule were also excluded from the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

glucosamine sulphate capsules

Active Comparator group

Description:

500 mg Glucosamine Compound, three times daily for 3 months following initial cause related therapy.

Treatment:

Drug: glucosamine sulphate

lactose capsules

Placebo Comparator group

Description:

lactose capsules three times daily for 3 months

Treatment:

Drug: lactose capsules